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Impact of Decision Aids on Bariatric Surgery Choice

Sponsor
Taipei Medical University Shuang Ho Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03578211
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
26.2
Actual Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sleeve gastrectomy, Roux-en-Y gastric bypass, laparoscopic gastric banding, and bioenteric intragastric balloon insertion are common types of bariatric surgeries. These treatment strategies have diverted outcomes in body weight loss, metabolic diseases control, surgical complications, and life quality improvement. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. Investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on obese patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and knowledge improvement. Investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Shared decision making with decision aids
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Impact of Decision Aids on Bariatric Surgery Choice: A Randomized Controlled Trial
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
May 16, 2020
Actual Study Completion Date :
Jul 7, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: DAs group

Shared decision making using decision aids

Behavioral: Shared decision making with decision aids
For obese patients, we use shared decision making with decision aids to help them choose the suitable types of bariatric surgery.
No Intervention: Control group

Standard oral explanation guided with booklets

Outcome Measures

Primary Outcome Measures

  1. Decisional conflict [One week after intervention]

    Total scores of decisional conflict scale

Secondary Outcome Measures

  1. Decision regret [3 month after bariatric surgery]

    Total scores of decision regret

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Body mass index (BMI) ≧ 32 kg / m2 with obesity-related comorbidity

  2. Body mass index (BMI) ≧ 37 kg / m2

Exclusion Criteria:

  1. Endocrine system abnormalities in patients

  2. Drug abuse or mental illness

  3. Major organ dysfunction and can accept surgery

  4. Patients cannot understand Chinese

  5. Age less than 20 years old or more than 70 years old

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Medical University-Shuang Ho Hospital New Taipei City Zhonghe District Taiwan 23561

Sponsors and Collaborators

  • Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: Yen-Hao Su, MD, Metabolic and Weight Management Center, Shuang-Ho Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SU YEN-HAO, Director of Metabolic and Weight Management Center, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier:
NCT03578211
Other Study ID Numbers:
  • N201804032
First Posted:
Jul 6, 2018
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obesity, Morbid

Study Results

No Results Posted as of May 5, 2022